MAUDE Adverse Event Report: DJO, LLC COOL, X-ACT ROM LITE, POST OP; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-2161-9

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.If it becomes available, a follow-up report will be submitted upon completion of the evaluation.

Event Description

It was reported that there were loose screws at the hinge component of the brace.The patient received the brace on (b)(6) 2018 following left knee surgery.The patient notified the physiotherapy department on (b)(6) 2018 to report the loose screws.The patient was fitted with a new brace on (b)(6) 2018.No further information has been provided.

• Brand Name: COOL, X-ACT ROM LITE, POST OP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8491127
• MDR Text Key: 141184021
• Report Number: 9616086-2019-00016
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11-2161-9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1